OFFICIAL-SOURCE RECALL · AUSTRALIA
Percussionaire IPV Systems Recall: Classification Class I Reason for the Action
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Why this product was recalled
Classification Class I Reason for the Action Percussionaire Corporation has recently received a complaint regarding the use of IPV therapy administered in-line to a mechanically ventilated, sedated patient receiving volatile anaesthetic agents using a Sedaconda system. In this event, the patient's sedation was reduced during concomitant use of the two therapies, resulting in reduced depth of sedation. Percussionaire is updating the Instructions for Use to warn users of use of IPV therapy in conjunction with any method of volatile anaesthetic administration, as concomitant use may interfere with anaesthetic delivery and pose a risk of patient harm. To date, Percussionaire has received one reported adverse event related to this problem, in which the patient experienced reduced sedation, necessitating cessation of IPV therapy to prevent the occurrence of serious adverse effects. Instructions for Customers/Users • Percussionaire is updating the product Instructions for Use to include a warning about using IPV therapy with volatile anaesthetic systems. • Customers are to review the new warning statement for IPV devices. • Customer training will be updated to include a warning about usin
Hazard
Classification Class I Reason for the Action Percussionaire Corporation has recently received a complaint regarding the use of IPV therapy administered in-line to a mechanically ventilated, sedated patient receiving volatile anaesthetic agents using a Sedaconda system. In this event, the patient's sedation was reduced during concomitant use of the two therapies, resulting in reduced depth of sedation. Percussionaire is updating the Instructions for Use to warn users of use of IPV therapy in conjunction with any method of volatile anaesthetic administration, as concomitant use may interfere with anaesthetic delivery and pose a risk of patient harm. To date, Percussionaire has received one reported adverse event related to this problem, in which the patient experienced reduced sedation, necessitating cessation of IPV therapy to prevent the occurrence of serious adverse effects. Instructions for Customers/Users • Percussionaire is updating the product Instructions for Use to include a warning about using IPV therapy with volatile anaesthetic systems. • Customers are to review the new warning statement for IPV devices. • Customer training will be updated to include a warning about usin
Official recall notice
Percussionaire IPV Systems
Agency: Therapeutic Goods Administration
Official publication date: August 21, 2026
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